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FDA 510(k)

STAODYN TUWAVE

K-Number: K921668 · 1992-08-03

ApplicantStaodyne, Inc.
Decision Date1992-08-03
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STAODYN TUWAVE is the device name listed in this FDA 510(k) record. The listed applicant is Staodyne, Inc.. It received FDA 510(k) clearance on 1992-08-03 under 510(k) number K921668. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAODYN TUWAVE?

STAODYN TUWAVE is a medical device that received FDA 510(k) clearance on 1992-08-03. The listed applicant is Staodyne, Inc.. The 510(k) number is K921668.

When did STAODYN TUWAVE receive FDA 510(k) clearance?

STAODYN TUWAVE received FDA 510(k) clearance on 1992-08-03, under 510(k) number K921668.

Who is the listed applicant for STAODYN TUWAVE?

The FDA 510(k) record lists Staodyne, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STAODYN TUWAVE?

The FDA product code for STAODYN TUWAVE is IPF.

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Other records listing Staodyne, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: IPF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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